Key result
Telmisartan/hydrochlorothiazide 80/25 mg reduced mean systolic blood pressure more than telmisartan 80 mg monotherapy (adjusted mean difference -10.6 mmHg; 95% CI -15.6 to -5.7).
Why the study?
Does telmisartan/hydrochlorothiazide 80/25 mg single-pill combination reduce systolic blood pressure compared to telmisartan 80 mg monotherapy in Chinese and Korean patients with moderate to severe hypertension?
RCT (n=888)
double-blind
randomized
Yes
Does telmisartan/hydrochlorothiazide 80/25 mg single-pill combination reduce systolic blood pressure compared to telmisartan 80 mg monotherapy in Chinese and Korean patients with moderate to severe hypertension?
Mean Difference: -10.6 (95% CI -15.6–-5.7)
Absolute Event Rate: -37.5% vs -26.9%
In Chinese and Korean patients with moderate-to-severe hypertension, a single-pill combination of telmisartan 80 mg and hydrochlorothiazide 25 mg significantly reduces systolic and diastolic blood pressure compared to telmisartan 80 mg monotherapy.
Supports telmisartan/HCTZ 80/25 mg over monotherapy for greater SBP reduction; extends RCT evidence to Chinese and Korean patients.
Background Hypertension is an important issue in Asia, responsible for up to 66% of cardiovascular disease cases. This randomized controlled trial subgroup analysis compared telmisartan 80 mg (T80)/hydrochlorothiazide 25 mg (H25) single-pill combination with T80 monotherapy, specifically in Chinese and Korean patients. Methods Patients with grade 2/3 hypertension were randomized to receive telmisartan 40 mg (T40)/hydrochlorothiazide 12.5 mg (H12.5) combination or T40 monotherapy for one week, before uptitrating the dose to T80/H25 or T80, respectively, for the remaining 6 weeks. The primary endpoint was systolic blood pressure (SBP) mean change from baseline. Secondary endpoints included mean diastolic blood pressure (DBP) change from baseline, and blood pressure (BP) goal achievement. Adverse events were recorded. Results Of a total 888 patients who were treated, efficacy analyses for Chinese and Korean patients included 127 patients treated with T80/H25 and 54 patients treated with T80. At week 7, mean SBP reductions from baseline were −37.5 mmHg (1 mmHg=0.133 kPa) and −26.9 mmHg in the T80/H25 and T80 groups (adjusted mean difference, −10.6 mmHg; 95% confidence interval ( CI ), −15.6 to −5.7). Mean DBP reductions were −19.0 and −14.1 mmHg in the T80/H25 and T80 groups (adjusted mean difference, −4.9 mmHg; 95% CI, −8.0 to −1.8). In total, 56.7% of patients receiving T80/ H25 achieved BP goal (<140/90 mmHg) compared with 35.2% receiving T80. SBP goal attainment (<140 mmHg) and DBP goal attainment (<90 mmHg) were also higher in the T80/H25 group compared with the T80 group (SBP: 69.3% vs. 48.1%; DBP: 62.2% vs. 46.3%). A small number of treatment-related adverse events were observed in both T80/H25 (nine patients, 6.9%) and T80 monotherapy (two patients, 3.6%) groups. Conclusions In Chinese and Korean patients with moderate-to-severe hypertension, treatment with T80/H25 provided large reductions in mean SBP and DBP, and high BP goal attainment rates. This once-daily combination is effective and well tolerated in this patient group. (ClinicalTrials.gov identifier NCT00926289)
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Zhu et al. (2013) conducted an RCT in moderate to severe hypertension (n=888). telmisartan/hydrochlorothiazide single-pill combination vs. telmisartan 80 mg monotherapy was evaluated on systolic blood pressure (SBP) mean change from baseline (adjusted mean difference -10.6 mmHg, 95% CI -15.6 to -5.7). Telmisartan/hydrochlorothiazide 80/25 mg reduced mean systolic blood pressure more than telmisartan 80 mg monotherapy (adjusted mean difference -10.6 mmHg; 95% CI -15.6 to -5.7).
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